Portola Pharmaceuticals (NASDAQ:PTLA) received its first FDA approval recently for a drug called Bevyxxa, but that's not the only reason why investors are taking notice of the company.
In this segment from Industry Focus: Healthcare, Motley Fool analyst Kristine Harjes and contributor Todd Campbell discuss the most exciting and promising drug in Portola's pipeline today, and why companies like Johnson & Johnson and Pfizer are so eager to help the young biotech develop it.
A full transcript follows the video.
This video was recorded on June 28, 2017.
Kristine Harjes: When you talk about adoption, and whether doctors will immediately flock toward this new drug as opposed to Lovenox, that brings us to the other side of the Portola story. One potential hurdle that these Xa inhibitors have to overcome is the fact that there is no currently approved antidote. When you think about a blood thinner, you also have to keep in mind that sometimes patients who are on blood thinners have unexpected major bleeding events, or they'll need an emergency surgery, and in those situations, you need to have an antidote on hand to stop the effects of the blood thinner.
Todd Campbell: Right. Warfarin was, for 50 years, the leading anticoagulant. It still has 40% market share in the indication. And that's easily reversed by giving vitamin K. That's one of the reasons that warfarin is actually losing market share, because it interacts with vitamin K and causes people to have severe dietary restrictions. So, warfarin has this antidote, and it's one of the reasons it's been so widely used, and it's still widely used in a lot of elderly patients who could be subject to, say, a fall, or something that would cause a bleeding event. So the thinking here is, if you can get an antidote approved by the FDA that would reverse these factor Xas, the top-selling of which are Xarelto, which is a J&J drug teamed up with Bayer, and Eliquis, which is a Pfizer drug teamed up with Bristol-Myers, then that antidote could also become an important top-selling drug.
Harjes: Right. And Portola is developing exactly that. They are very close to the finish line at this point. They have already filed for approval once. The approval unfortunately did not come. They received a complete response letter, a CRL, which is not a good sign. But, when you look into the details of their CRL, it was due to manufacturing issues and a request for another piece of data specifically about how this drug works to reverse the effects of some of the lesser-known, less commonly used factor Xa inhibitors. So, this wasn't the FDA saying, "Your drug doesn't work." This was the FDA saying, "We need you to tweak a couple of things in the manufacturing process and provide us with a little bit more data, and then we'll reconsider."
Campbell: As a refresher, this is a drug that, its competitors theoretically really want to see get approved. Pfizer, Bristol-Myers, Johnson & Johnson, they all helped provide financing for AndexXa's trials. They really want to see this drug get across the finish line.
Harjes: I wrote an article a long time ago, something about the little biotech that's getting a free lunch from big pharma, and that's because Portola is getting so much money handed to them from these big pharmas that aren't even demanding that much back from Portola, because these companies just want to see an antidote on the market to then boost their own drugs.
Campbell: Absolutely. The more of that warfarin market share you can chip away at, the better -- that's the way they're looking at it. AndexXa, as it stands right now, is going to be refiled, according to management, for approval in August. Previously they were targeting July, now they're looking at August. Who knows how many months it will be before the FDA makes a ruling on it. Let's assume it gets approved late this year, early next year. That's big news, because Portola estimates about over 90,000 people could benefit from the use of this antidote per year. And depending on pricing, that could add a few hundred million dollars in revenue to the top line. So, now you have a potentially billion-dollar drug in Bevyxxa, and you have another few hundred million potentially coming in from AndexXa.